Committee Report

Report text available as:

111th Congress Rept. 111-618
HOUSE OF REPRESENTATIVES
2d Session Part 1
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SAFE DRUG DISPOSAL ACT OF 2010
_______
September 22, 2010.--Committed to the Committee of the Whole House on
the State of the Union, and ordered printed
_______
Mr. Waxman, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 5809]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 5809) to amend the Controlled Substances Act to
provide for take-back disposal of controlled substances in
certain instances, and for other purposes, having considered
the same, report favorably thereon with an amendment and
recommend that the bill as amended do pass.
CONTENTS
Page
Amendment........................................................ 1
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 3
Committee Consideration.......................................... 4
Committee Votes.................................................. 5
Committee Oversight Findings and Recommendations................. 5
New Budget Authority, Entitlement Authority, and Tax Expenditures 5
Statement of General Performance Goals and Objectives............ 5
Constitutional Authority Statement............................... 5
Earmarks and Tax and Tariff Benefits............................. 6
Federal Advisory Committee Statement............................. 6
Applicability of Law to Legislative Branch....................... 6
Federal Mandates Statement....................................... 6
Committee Cost Estimate.......................................... 6
Congressional Budget Office Cost Estimate........................ 6
Section-by-Section Analysis of the Legislation................... 7
Changes in Existing Law Made by the Bill, as Reported............ 8
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Safe Drug Disposal Act of 2010''.
SEC. 2. DELIVERY OF CONTROLLED SUBSTANCES BY ULTIMATE USERS FOR
DISPOSAL.
(a) Regulatory Authority.--Section 302 of the Controlled Substances
Act (21 U.S.C. 822) is amended by adding at the end the following:
``(g)(1) An ultimate user who has lawfully obtained a controlled
substance in accordance with this title may, without being registered,
deliver the controlled substance to another person for the purpose of
disposal of the controlled substance if--
``(A) the person receiving the controlled substance is
authorized under this title to receive and dispose of the
controlled substance; and
``(B) the delivery and disposal takes place in accordance
with regulations issued by the Attorney General to prevent
diversion of controlled substances.
The regulations referred to in subparagraph (B) shall be consistent
with the public health and safety. In developing such regulations, the
Attorney General shall take into consideration the ease and cost of
program implementation and participation by various communities. Such
regulations may not require any entity to establish or operate a
delivery or disposal program.
``(2) The Attorney General shall, by regulation, authorize long-term
care facilities, as defined by the Attorney General by regulation, to
deliver for disposal controlled substances on behalf of ultimate users
in a manner that the Attorney General determines will provide effective
controls against diversion and be consistent with the public health and
safety.
``(3) If a person dies while lawfully in possession of a controlled
substance for personal use, any person lawfully entitled to dispose of
the decedent's property may deliver the controlled substance to another
person for the purpose of disposal under the same conditions as
provided in paragraph (1) for an ultimate user.''.
(b) Conforming Amendment.--Section 308(b) of the Controlled
Substances Act (21 U.S.C. 828(b)) is amended--
(1) by striking the period at the end of paragraph (2) and
inserting ``; or''; and
(2) by adding at the end the following:
``(3) the delivery of such a substance for the purpose of
disposal by an ultimate user, long-term care facility, or other
person acting in accordance with section 302(g).''.
SEC. 3. PUBLIC EDUCATION CAMPAIGN.
The Director of National Drug Control Policy, in consultation with
the Administrator of the Environmental Protection Agency, shall carry
out a public education and outreach campaign to increase awareness of
how ultimate users may lawfully and safely dispose of prescription
drugs, including controlled substances, through drug take-back programs
and other appropriate means.
SEC. 4. GAO REPORT.
The Comptroller General of the United States shall--
(1) collect data on the delivery, transfer, and disposal of
controlled substances under section 302(g) of the Controlled
Substances Act, as added by section 2; and
(2) not later than 4 years after the date of the enactment of
this Act, submit findings and recommendations to the Congress
regarding use, effectiveness, and accessibility of disposal
programs.
SEC. 5. EPA STUDY OF ENVIRONMENTAL IMPACTS.
(a) Study.--The Administrator of the Environmental Protection Agency
(in this section referred to as the ``Administrator'') shall--
(1) in consultation with relevant State and local officials
and other sources of relevant technical expertise, conduct a
study to--
(A) examine the environmental impacts resulting from
the ultimate disposal of controlled substances through
existing methods;
(B) taking into consideration such impacts, and the
ease and cost of implementation of drug take-back
programs and participation in such programs by various
communities, formulate appropriate recommendations on
the destruction or ultimate disposal of prescription
drugs, including controlled substances; and
(C) identify additional authority needed to carry out
such recommendations if the Administrator determines
that the Administrator's existing legal authorities are
insufficient to implement such recommendations; and
(2) not later than 18 months after the date of the enactment
of this Act, submit a report to the Congress on the results of
such study.
(b) Rule of Construction.--Nothing in this section shall be construed
to affect the Administrator's authority under other provisions of law.
Purpose and Summary
H.R. 5809, the ``Safe Drug Disposal Act of 2010'', was
introduced by Representatives Jay Inslee (D-WA), Lamar Smith
(R-TX), Bart Stupak (D-MI), and James P. Moran (D-VA) on July
21, 2010. The bill was referred to the Committee on Energy and
Commerce, and in addition to the Committee on the Judiciary.
The legislation has two overriding goals:
To allow individuals, as well as long-term care
facilities on behalf of their patients, to deliver unused
prescription drugs to an appropriate person for disposal
purposes, as determined by the Attorney General.
To enhance understanding of the environmental
impacts of the disposal of unused medicines through existing
methods.
Background and Need for Legislation
The abuse of prescription medications is a growing public
health concern in the United States. According to the 2010
National Drug Control Strategy released by the White House,
prescription drug abuse is the fastest growing drug problem in
the United States.\1\ Several recent studies underscore this
point:
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\1\Office of National Drug Control Policy, The 2010 National Drug
Control Strategy, p. 29 (online at www.whitehousedrugpolicy.gov/
publications/policy/ndcs 10/ndcs2010.pdf).
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In a study released in July 2010, the Substance
Abuse and Mental Health Services Administration (SAMHSA) found
that between 1998 and 2008 there was a 400% increase in
hospital admissions for those aged 12 and over reporting abuse
of prescription pain relievers.\2\
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\2\Substance Abuse and Mental Health Services Administration,
Substance Abuse Treatment Admissions Involving Abuse of Pain Relievers:
1998-2008 (July 15, 2010) (online at oas.samhsa.gov/2k10/230/
230PainRelvr2k10Web.pdf).
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In a report published in June 2010, the Centers
for Disease Control and Prevention (CDC) noted that emergency
department visits associated with non-medical use of
prescription controlled substances doubled between 2004 and
2008, reaching a million visits.\3\
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\3\Centers for Disease Control and Prevention, Emergency Department
Visits Involving Nonmedical Use of Selected Prescription Drugs--United
States, 2004-2008 (June 18, 2010) (online at www.cdc.gov/mmwr/preview/
mmwrhtml/mm5923al.htm).
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In a 2008 study, SAMHSA found that youth between
the ages of 12 and 17 abuse prescription drugs more often than
cocaine, heroin, and methamphetamine combined.\4\ It also
showed that the scale of the problem is vast: more than six
million Americans used a prescription medication for nonmedical
purposes in a one-month period. The study further found that
70% of people who abuse prescription pain relievers obtained
them from friends or relatives who had obtained them from a
doctor.
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\4\Substance Abuse and Mental Health Services Administration,
Results from the 2008 National Survey on Drug Use and Health, p. 15-30
(online at www.oas.samhsa.gov/nsduh/2k8nsduh/2k8Results.pdf).
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Drug take-back programs are one way to help address this
growing and serious problem. As noted, a major factor in the
increasing trend of prescription drug abuse is the availability
of such drugs in the home. These programs provide a means by
which patients can safely dispose of their unused medicines.
Such programs also decrease the amount of pharmaceuticals that
might otherwise enter waterways via municipal waste water
systems if such pharmaceuticals are flushed down the toilet.
According to the Environmental Protection Agency, we know
that pharmaceuticals have health effects at the therapeutic
dose, but we do not know if there are effects to human health
associated with long-term exposure to pharmaceuticals at much
lower concentrations in drinking water. Some laboratory and
other studies have demonstrated effects on fish and aquatic
life of low-level exposure to pharmaceuticals. There are no
known human health effects of low-level exposures to
pharmaceuticals in drinking water in the general population,
but EPA believes that more investigation is required to
determine whether sensitive human populations (such as
developing fetuses) are experiencing such effects.
Under current law, the Controlled Substances Act (CSA)
creates a barrier for many drug take-back programs. The CSA
regulates controlled substances\5\ through a closed
registration system designed to prevent diversion.\6\ Under
this system, any entity other than the ``ultimate user'' (i.e.,
the patient who is prescribed a controlled pharmaceutical) who
receives or distributes a controlled substance must be
registered with the Drug Enforcement Administration (DEA). In
other words, although patients do not have to be registered
with DEA in order to receive a controlled substance, they
cannot lawfully deliver a controlled substance to another
entity for any purpose, including disposal of the drug.\7\
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\5\Controlled substances are those substances listed in the
schedules of the CSA and 21 CFR 1308.11-1308.15, and generally include
drugs that have a potential for abuse and physical and psychological
dependence, such as narcotics, stimulants, depressants, anabolic
steroids and hallucinogens.
\6\Drug Enforcement Administration, Testimony for the Special
Committee on Aging Hearing on Drug Waste and Disposal: When
Prescriptions Become Poison, Statement of Joseph T. Rannazzisi, p. 3
(June 30, 2010) (hereinafter, ``DEA Testimony'') (online at
aging.senate.gov/events/hr223gk.pdf).
\7\Id.
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Under current law as well, the only entities authorized to
take possession of expired or otherwise unwanted controlled
substances for the purpose of disposal are known as ``reverse
distributors.'' Other registrants, such as pharmacies, may
dispose of controlled substances already in their possession
(for instance, if they are expired, damaged, or contaminated),
but may not accept controlled substances from patients or any
other person solely for the purpose of disposal.\8\
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\8\21 CFR 1300.01(b)(41).
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In January 2009, in response to growing concerns raised by
individuals, interest groups, the healthcare industry, and the
law enforcement community, DEA solicited public comments on the
disposal of controlled substances dispensed to individual
patients, as well as to long-term care facilities. Although DEA
received numerous responses during the public comment period
(which ended on March 23, 2009), the agency has stated it
cannot move forward with a regulatory proposal in the absence
of authorizing legislation.\9\
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\9\DEA Testimony, supra note 6, at 5.
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Committee Consideration
H.R. 5809, the ``Safe Drug Disposal Act of 2010'', was
introduced by Representatives Inslee (D-WA), Smith (R-TX),
Stupak (D-MI), and Moran (D-VA) on July 21, 2010, and referred
to the Committee on Energy and Commerce, and subsequently to
the Subcommittee on Health on the same day. The Subcommittee on
Health conducted a legislative hearing on the bill and
afterwards met in open markup session to consider H.R. 5809 on
July 22, 2010. An amendment in the nature of a substitute
(manager's amendment) by Representative Stupak was adopted by a
voice vote. Subsequently, H.R. 5809 was favorably forwarded to
the full Committee, amended, by a voice vote.
On July 28, 2010, the Committee on Energy and Commerce met
in open markup session and considered H.R. 5809 as approved by
the Subcommittee. An amendment in the nature of a substitute
(manager's amendment) offered by Representative Pallone (D-NJ)
was adopted by a voice vote. Subsequently, the Committee
ordered H.R. 5809 favorably reported to the House, amended, by
a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. A
motion by Mr. Waxman ordering H.R. 5809 reported to the House,
amended, was approved by a voice vote. There were no record
votes taken during consideration of this bill.
Committee Oversight Findings and Recommendations
In compliance with clause 3(c)(1) of rule XIII and clause
2(b)(1) of rule X of the Rules of the House of Representatives,
the oversight findings and recommendations of the Committee are
reflected in the descriptive portions of this report, including
the finding that drug take-back programs provide one means of
addressing the growing and serious problem of prescription drug
abuse.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Regarding compliance with clause 3(c)(2) of rule XIII of
the Rules of the House of Representatives, the Committee finds
that H.R. 5809 would result in no new budget authority,
entitlement authority, or tax expenditures or revenues.
Statement of General Performance Goals and Objectives
In accordance with clause 3(c)(4) of rule XIII of the Rules
of the House of Representatives, the performance goals and
objectives of the Committee are reflected in the descriptive
portions of this report, including the goal of facilitating the
delivery of unused prescription drugs to appropriate persons
for disposal purposes, and enhancing scientific understanding
of the environmental impacts of the disposal of unused
medicines through existing methods.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
constitutional authority for H.R. 5809 is provided under
Article I, section 8, clauses 3 and 18 of the Constitution of
the United States.
Earmarks and Tax and Tariff Benefits
H.R. 5809 does not contain any congressional earmarks,
limited tax benefits, or limited tariff benefits as defined in
clause 9(d), 9(e), or 9(f) of rule XXI of the Rules of the
House of Representatives.
Federal Advisory Committee Statement
The Committee finds that the legislation does not establish
or authorize the establishment of an advisory committee within
the definition of 5 U.S.C. App., section 5(b) of the Federal
Advisory Committee Act.
Applicability of Law to the Legislative Branch
Section 102(b)(3) of Public Law 104-1 requires a
description of the application of this bill to the legislative
branch where the bill relates to terms and conditions of
employment or access to public services and accommodations.
H.R. 5809 contains no such provisions.
Federal Mandates Statement
Section 423 of the Congressional Budget and Impoundment
Control Act of 1974 (as amended by section 101(a)(2) of the
Unfunded Mandates Reform Act, P.L. 104-4) requires a statement
on whether the provisions of the report include unfunded
mandates. In compliance with this requirement the Committee
adopts as its own the estimates of federal mandates prepared by
the Director of the Congressional Budget Office.
Committee Cost Estimate
Pursuant to clause 3(d)(2) of rule XIII of the Rules of the
House of Representatives, the Committee adopts as its own the
cost estimate of H.R. 5809 prepared by the Director of the
Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
Congressional Budget Office Cost Estimate
With respect to the requirements of clause (3)(c)(3) of
rule XIII of the Rules of the House of Representatives and
section 402 of the Congressional Budget Act of 1974, the
Committee has received the following cost estimate for H.R.
5809 from the Director of the Congressional Budget Office:
August 5, 2010.
Hon. Henry A. Waxman,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 5809, the Safe
Drug Disposal Act of 2010.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Mark
Grabowicz.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 5809--Safe Drug Disposal Act of 2010
CBO estimates that implementing H.R. 5809 would cost about
$2 million in fiscal year 2011 and less than $500,000 annually
over the 2012-2014 period, from appropriated amounts. The bill
would not affect direct spending or revenues; therefore, pay-
as-you-go procedures do not apply. H.R. 5809 contains no
intergovernmental or private-sector mandates as defined in the
Unfunded Mandates Reform Act and would impose no costs on
state, local, or tribal governments.
H.R. 5809 would require the Department of Justice (DOJ) to
authorize long-term care facilities (such as nursing homes) to
arrange for the appropriate disposal of certain controlled
substances. Based on information from DOJ, CBO estimates that
implementing the bill would not significantly affect the
department's spending on drug control programs.
In addition, H.R. 5809 would direct the Office of National
Drug Control Policy to carry out a public outreach campaign
relating to the safe disposal of prescription drugs. H.R. 5809
also would require the Environmental Protection Agency (EPA) to
conduct a study on the environmental impacts of disposing of
controlled substances and would require the Government
Accountability Office (GAO), within four years of the date of
enactment, to prepare a report on implementation of the bill's
provisions.
Based on the costs of similar activities, CBO estimates
that the public outreach campaign and the EPA study would cost
about $1 million each in 2011 and the GAO report would cost
less than $500,000 annually over the 2011-2014 period, from
appropriated funds.
On August 3, 2010, CBO transmitted a cost estimate for S.
3397, the Secure and Responsible Drug Disposal Act of 2010, as
reported by the Senate Committee on the Judiciary on July 29,
2010. The two bills are similar, but S. 3397 did not require a
public outreach campaign or any reports and we estimated that
its implementation would have no significant cost to the
federal government.
The CBO staff contact for this estimate is Mark Grabowicz.
The estimate was approved by Theresa Gullo, Deputy Assistant
Director for Budget Analysis.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates that the short title may be cited as
the ``Safe Drug Disposal Act of 2010''.
Section 2. Delivery of controlled substances by ultimate users for
disposal
Section 2 amends the Controlled Substances Act to permit an
ultimate user who has lawfully obtained a controlled substance
and who is not registered with the DEA to deliver that
controlled substance to another person for the purpose of
disposal if the person receiving the controlled substance is
authorized to do so under the Act, and if the delivery and
disposal takes place in accordance with regulations to be
issued by the Attorney General to prevent diversion of
controlled substances. In developing such regulations, the
Attorney General is to consider both the ease and cost of
program implementation and participation by various
communities. The legislation prohibits the DEA from requiring
any entity to establish a drug take back program.
Section 2 also requires the Attorney General to issue
regulations to authorize long-term care facilities to deliver
for disposal controlled substances on behalf of ultimate users.
In addition, Section 2 authorizes any person lawfully
entitled to dispose of a decedent's property to deliver
controlled substances belonging to that decedent to another
person for the purpose of disposal.
Section 3. Public education campaign
Section 3 requires the Director of National Drug Control
Policy (ONDCP), in consultation with EPA, to carry out a public
education and outreach campaign to increase awareness of drug
take-back programs.
Section 4. GAO report
Section 4 requires the Comptroller General to submit a
report to Congress on the delivery, transfer, and disposal of
controlled substances under the Controlled Substances Act (as
amended by the legislation) that includes findings and
recommendations regarding the use, effectiveness, and
accessibility of drug disposal programs.
Section 5. EPA study of environmental impacts
Section 5 requires the EPA administrator, in consultation
with relevant state and local officials and other relevant
experts, to conduct a study to:
Examine the environmental impacts from the final
disposal of controlled substances through existing methods.
Consider the ease and cost of implementation of
drug take-back programs, and participation in such programs by
various communities.
Make recommendations on the appropriate ways to
dispose of prescription drugs.
Identify additional authority needed to carry out
such recommendations if the Administrator determines that
existing legal authorities are insufficient to implement them.
EPA is required to submit the results of the study to
Congress within 18 months of the enactment of the legislation.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
CONTROLLED SUBSTANCES ACT
* * * * * * *
TITLE II--CONTROL AND ENFORCEMENT
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances; Piperidine Reporting
* * * * * * *
PERSONS REQUIRED TO REGISTER
Sec. 302. (a) * * *
* * * * * * *
(g)(1) An ultimate user who has lawfully obtained a
controlled substance in accordance with this title may, without
being registered, deliver the controlled substance to another
person for the purpose of disposal of the controlled substance
if--
(A) the person receiving the controlled substance is
authorized under this title to receive and dispose of
the controlled substance; and
(B) the delivery and disposal takes place in
accordance with regulations issued by the Attorney
General to prevent diversion of controlled substances.
The regulations referred to in subparagraph (B) shall be
consistent with the public health and safety. In developing
such regulations, the Attorney General shall take into
consideration the ease and cost of program implementation and
participation by various communities. Such regulations may not
require any entity to establish or operate a delivery or
disposal program.
(2) The Attorney General shall, by regulation, authorize
long-term care facilities, as defined by the Attorney General
by regulation, to deliver for disposal controlled substances on
behalf of ultimate users in a manner that the Attorney General
determines will provide effective controls against diversion
and be consistent with the public health and safety.
(3) If a person dies while lawfully in possession of a
controlled substance for personal use, any person lawfully
entitled to dispose of the decedent's property may deliver the
controlled substance to another person for the purpose of
disposal under the same conditions as provided in paragraph (1)
for an ultimate user.
* * * * * * *
ORDER FORMS
Sec. 308. (a) * * *
(b) Nothing in subsection (a) shall apply to--
(1) * * *
(2) the delivery of such a substance to or by a
common or contract carrier for carriage in the lawful
and usual course of its business, or to or by a
warehouseman for storage in the lawful and usual course
of its business; but where such carriage or storage is
in connection with the distribution by the owner of the
substance to a third person, this paragraph shall not
relieve the distributor from compliance with subsection
(a)[.]; or
(3) the delivery of such a substance for the purpose
of disposal by an ultimate user, long-term care
facility, or other person acting in accordance with
section 302(g).
* * * * * * *